When I worked on a lot of quick Phase I and II studies, I probably completed about 30 trials that year because the studies only looked at a small number of participants (<100) and lasted less than a month. These studies only required one initiation, one monitoring visit and one close out visit per site. However, for the last two years, I've been working on one study and one study only. This study has over 5,000 patients and lasts over 5 years. This study will require one initiation visit, up to forty monitoring visits and one close out visit per site.

It not only depends on the type of studies you are on either... It also depends on company philosophy. Some companies prefer to give CRAs fewer studies (1-2), but they will have to travel further to their study sites. Other companies do not like their CRAs to travel as much, so they give them local sites that they can drive to- but because you cover a smaller area, you need to work on a greater number of protocols (sometimes up to 20 protocols!)

Personally, I feel like the method of giving CRAs fewer protocols is a better because it increases quality and allows CRAs to be experts in their therapeutic area. I feel it really effects monitoring quality if you are on too many protocols and are unable to keep the details straight between them. Regardless of monitor experience, it's just impossible to be an expert on 15 protocols at one time.

Hello Mather, thank you so much for your response. it was very helpful. I also have another question if you do not mind.

1.With the exception of travelling, what is the most challenging thing about your job.
2.Does your company provide templates for reports, for instance Site initiation report, follow-up visit reports and close out reports.
3. what steps do you take if you notice during one of your visits that an ADR was not repoeted to the sponsor within 24 hrs as specified by the protocol. Or not reported at all?

1. Dealing with people that are not motivated to do their job well. It's easy to educate someone who wants to learn, but when you try and try to motivate overstressed, overworked CRCs that have just given up, it's a new level of complication.

2. Yes, all companies have something called a "Standard Operating Procedures." Even contractors that are not employees must follow SOPs for each type of visit. There are a different SOP for each type of visit. The SOP will tell you every thing that you need to do at every visit and will have a standard report template. Sometimes, a study will have a special quirk or there will be a sponsor request and that will require a specific question(s) to be added to the template.

3. This is one THE most common interview questions you will get asked for a CRA position, so it's extremely important for an applicant to have an idea of how to manage this situation. Fortunately, this process is spelled out in the SOP and monitoring plan- so much so that I don't think it would be ethical to post online. When you are answering this question in an interview, don't just limit yourself to what the SOP states, make sure to highlight your 'soft skills' that you will use to solve the problem as well.

I currently have a BS in life sciences and I am thinking about getting a masters degree. I am not exactly sure what area of studies will be beneficial for a CRA career. I know you have a lot of experience as a CRA and will be in a better position to tell me what area of studies will be beneficial. Will an MBA be beneficial?

A CRA should have at least 2 years WORK experience in the clinical research field and a Bachelor's degree in the life sciences. Nothing else is needed to get your career started.

After 4 years of being a CRA, I went back to study something I had a personal interest in for my Master's. Getting the Master's degree did not result in any raise or promotion. One of my fellow CRAs on my current study has a MBA. She got this after being a CRA for a few years. It also did not result in a raise or promotion. It WILL probably help a few years down the line when we are looking to transition into project management- but as for right now, a Master's degree has not done anything to improve my or my colleagues' career as a CRA. It's very rare to see anyone hired with a Master's degree. The most desirable degree is a BSN or a BS.

The one credential that I can say DID help was getting my CCRA certification from ACRP. Unfortunately, you do not qualify to sit for the certified CRA test until you've been a CRA for 2 years, so it isn't something you can get now, but it's something to consider. After becoming certified, I got a $2k raise immediately and a promotion the next cycle.

Overall, it's important to remember that a Master's degree doesn't make you look 'special' for an entry level CRA job- it makes you look overqualified. The most important thing for an entry level CRA to have is a robust work experience. Especially in this field, Master's degrees should NEVER be sought for career development, but instead the personal joy of studying something you love.

I came across a job desciption for a CRA position and assisting in patient recruitment was one of the requirements. I suppose it can be a daunting task to recurit patients because they have to qualify for that particular study. With the exception of posting flyers at hospitals and schools what other ways have you increased patient recruitment in the past.

Physically recruiting the patient is NOT a duty of a CRA. Actually getting patients in the door is the responsibility of the PI (ICH GCP 4.2.1), but it is almost always delegated a position called a CRC (clinical researchcoordinator) or SC (study coordinator). As a CRA, you will be assigned to up to 20 different research sites in probably more than a dozen states across the country. Logistically, it's impossible for a CRA to play and active role in patient recruitment.

ICG GCP 5.18 lists the duties of the CRA. It states that a CRA is responsible to recruit the recruitment rate to the sponsor. Typically, this is done through weekly calls to the coordinators. Every week, you'll call each of your sites and ask about recruitment, number of screenings they have scheduled, if they have ads running and what they are doing to get patients in to screen. If a site is having trouble recruiting the CRA can share success stories from their other sites, motivation calls, help the site get additional funds for advertisements, offer incentives or if a particular inclusion/exclusion criterion is posing a problem, the CRA can convey that message to the sponsor to see if a protocol waiver or revision may be needed. Also, the CRA is a very important resource for the CRC to call if they are unsure if a potential subject may or may not be a good candidate for a trial. This is where the CRAs responsibility ends.

Just if you are curious, here are things that CRCs do to recruit subjects:
-Recruit from their patient databases
-Recruit from PI's private practice patients
-Form collaborative relationships with physicians and free clinics in the area to gain referrals
-Buy advertising space for IRB-approved materials in newspapers, online sites, televisions, radio, etc
-Use a recruiting firm
-Post flyers
-Refer-a-friend program
-Community outreach

Your Comment was helpful. From everything I have read, CRA's have a good career, I am just curious as to how the work load or protocols get assigned, what does a CRA do after recieving a protocol, who decides/ arranges when to schedule a visit or travel to a site.

The answer to your question is located in ICH GCP 5.18.1, 2, and 3. I won't bother to cover the basics because the guidelines explain it so clearly. Before you consider this career any further, take a few minutes to review ICH GCP guidelines. They are much easier to read than the CFR and they will give you the background information that you need. It is absolutely essential that every monitor read these guidelines and be able to use the knowledge contained in them everyday. Do a google search- it's free to learn and can easily be completed in an afternoon.

From a 'real life' perspective, workload can vary greatly among CRAs. Sometimes you'll have an easy, standard 40-hour work week, other weeks you'll easily be able to clock in 80-100 hours due to all the travel. It really depends.

When you get assigned to a protocol, the first thing to do is to read it! You will also complete and document all training on the protocol, IB, monitoring plan, budgets, and conventions for the study. Then, you'll do training and request access for IVRS, EDC, CTMS, etc. Since you don't always get the luxury of starting your participation on the protocol from the beginning, you will have to work with the previous CRAs so you are informed of the status of each of the sites assigned to you by the project managers.

Once you know the status of each of your sites, it is the sole responsibility of the CRA to schedule their visits and book their own travel to/from the site in accordance with the monitoring plan and also the budget practices of the company. The monitoring plan is written at the beginning of a study, typically by the lead CRA and it's approved by the sponsor. It specifies everything from what training you need to complete, how often you go to sites, what you are required to do at each visit, how to select casebooks for review, when to escalate major issues, fraud detection, etc.

Yes. CRAs are very independent and have to be very self-managing. After a year or two experience, CRAs typically work from home when they aren't traveling. It's likely that a CRA will only get to meet a few of their coworkers. Typically, the traveling is also done alone.

CRAs have multiple managers. You will have one 'line manger' that sticks with you all the time. I have never met my line manager. We talk on the phone for about half an hour every month or so. They are responsible for approving your timesheets, HR issues, expense reports, etc.

And then CRAs will have another manager(s) for every study they are assigned to. I email my study managers several times a week and only talk on the phone if something serious is noted at a site visit. I met my study manager once at the investigator meeting. We have a weekly phone telecon with all the managers and CRAs every week so everyone keeps up to date on the study status.

If you are a new CRA, you'll probably talk to the lead CRA or a manager at least a few times a week with questions. Also, if you aren't keeping up or there's concerns about performance you'll have much more contact with managers to help you prioritize and keep up with your work.

Since CRA's work on many projects at once how do you prioritize your work? Does the company provide management tools to help you stay organize? What advice can you give to someone new in the industry about staying organized and the best way to prioritize work beside adhering to dateline?

I hope you had a great holiday weekend. I need your expert advice on a question.

During interviews, some companies ask candidates if they are interviewing with other companies. I am always perplexed by this question and don't know how to answer because I do not know the real reason behind the question. I always tell the truth which is always "yes" because I always apply to more than one company. By saying "Yes" does that hurt my chances of getting a job offer? why do they ask?

Since CRA's work on many projects at once how do you prioritize your work?

Does the company provide management tools to help you stay organize? What advice can you give to someone new in the industry about staying organized and the best way to prioritize work beside adhering to dateline?

I always say that honesty is the best policy. I think they ask because they want to know if you are likely to play hardball in salary negotiations if offered the job... but I cannot be sure. That's not a question I would ever even think to ask during an interview.

I'd like to suggest that you join your local ACRP chapter and go participate in meetings. Get to know the CRAs in your area and offer to buy them lunch if they are willing to do some 'shop talk' with you about the industry. You may even ask someone to do a face-to-face mock interview with you. Don't just rely on one person either! CRAs have a vast number of strategies and work management techniques. I learn something new every time I go out for half-price happy hour with the other CRAs in my city!

Does a signed ICF have presidence over a hippaa form. Can a patients medical file be reviewed by a CRA with a signed consent form, and an unsigned Hippaa form in the folder.

How are documentation deviations handled in a clinical setting. Expecially in cases were the clinical site gets closed due to non conformance issues including documentation. Does the data get invalidated and not used for statistical analysis?

Hi Lucy, Please refer to 21CFR50.25(a). Think about these regulations in a problem-prevention way- not about what to do when a problem occurs. We already have to abide by 21CFR50.25(a)(5), why not include the HIPAA statement within the ICF? Proactive prevention of errors in much more important than reactive responses to when problems are encountered.

I recently had an interview for a full timeentry level CRA position, however I was also asked to complete a W-9 form. I thought W-9 are only for independent contractors. Is it a standarad procedure to fill out W-9 forms when interviewing for CRA positions?

At the interview it should be clear whether you are applying to a contract or a permanent position, so I believe that the W-9 was completed for your interview expenses. I haven't done this at all my interviews, but one company (major CRO) did request that I complete a W-9 to get reimbursed for interview expenses.